On May 20, 2021 GlaxoSmithKline reported that it has agreed with Innoviva, Inc ("Innoviva") – a royalty management company – to sell all of its approximately 32 million shares of common stock of Innoviva back to Innoviva at a price of $12.25 per share, raising gross proceeds of approximately $392 million (Press release, GlaxoSmithKline, MAY 20, 2021, View Source [SID1234580360]). Following settlement of the transaction, GSK will no longer hold any Innoviva stock.

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The terms of GSK’s long-standing and successful respiratory collaboration with Innoviva remain unchanged. Under this agreement GSK pays royalties to Innoviva on TRELEGY ELLIPTA, RELVAR/BREO ELLIPTA and ANORO ELLIPTA. In 2020, TRELEGY ELLIPTA sales were £819m (+59% CER (constant exchange rates)); RELVAR/BREO ELLIPTA sales were £1.1bn (+17% CER) and ANORO ELLIPTA sales were £547m (+8% CER).

This equity disposal releases capital to enable GSK to make further investment behind the Group’s strategic priorities.

Innoviva’s most recent closing share price was $12.29. The five-day volume weighted average price was $12.67.

On May 20, 2021 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies by overcoming tumor immune evasion and drug resistance, reported that it will present new data from the ongoing Phase 1/2 clinical trial of NT219 on Friday, June 4, 2021, at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, which will be held virtually from June 4-8 (Press release, Purple Biotech, MAY 20, 2021, View Source [SID1234580376]).

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NT219 is a dual inhibitor, novel small molecule that simultaneously targets IRS1/2 and STAT3. The Phase 1/2 trial is evaluating NT219 as monotherapy treatment of advanced solid tumors, as well as in combination with cetuximab, an epithelial growth factor receptor (EGFR) blocking monoclonal antibody, for the treatment of recurrent and/or metastatic solid tumors and head and neck cancer or colorectal adenocarcinoma.

"We are excited to present interim data from our ongoing Phase 1/2 clinical trial of NT219 as monotherapy for the treatment of solid tumors that has the potential to help people living with hard-to-treat cancers," said Bertrand Liang, M.D., Ph.D., Chief Medical Officer of Purple Biotech. "We are excited to have clinical data for our NT219 program and we continue to expect the availability of further top-line data from the first part of this study in the second half of this year."

Details of the presentation are as follows:

Title: A Phase 1/2 study with open-label, dose escalation phase followed by single-arm expansion at the maximum tolerated dose to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 injection alone and in combination with Cetuximab in Adults with Advanced Solid Tumors and Head and Neck Cancer.

Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

Location: ASCO (Free ASCO Whitepaper) Meeting Library

On May 20, 2021 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company developing a new class of potent and selective precision oncology medicines, which it refers to as Pentarin miniature drug conjugates, reported that the company will present data from its Phase 2 clinical trial of PEN-221 at the 2021 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting occurring virtually June 4-8, 2021 (Press release, Tarveda Therapeutics, MAY 20, 2021, View Source [SID1234580393]).

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PEN-221 is a miniature drug conjugate consisting of a peptide ligand that is highly selective in targeting the somatostatin receptor 2 (SSTR2), joined through a cleavable linker to the potent cytotoxic payload DM1. The Phase 2 trial assessed the safety, tolerability, pharmacokinetics, and preliminary efficacy of PEN-221 in well differentiated neuroendocrine tumors (NETs) and small cell lung cancer. The data being presented include safety and efficacy outcomes for patients enrolled in the gastrointestinal mid-gut NETs cohort.

"We are encouraged by the safety and efficacy results of our Phase 2 trial, which showed that PEN-221 was well tolerated and exceeded its clinical efficacy goals in patients with GI mid-gut neuroendocrine tumors," said Brian Roberts, President and Chief Executive Officer of Tarveda. "We look forward to presenting the results of the study at this year’s ASCO (Free ASCO Whitepaper) Annual meeting and to further evaluating PEN-221 in GI mid-gut neuroendocrine tumors."

Details of the poster presentation are as follows:

Title: The safety and efficacy of PEN-221 somatostatin analog (SSA)-DM1 conjugate in patients (PTS) with advanced GI mid-gut neuroendocrine tumor (NET): Phase 2 results.
Abstract Number: 4110
Date: Poster presentation available on demand beginning on June 4, 2021 at 9:00 AM ET

On May 20, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, reported that sacituzumab govitecan-hziy (SG) was granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) (Press release, Everest Medicines, MAY 20, 2021, View Source [SID1234580409]).

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This marks another progress following the Company’s announcement published on 17 May 2021 that the NMPA accepted its Biologics License Application (BLA) for SG for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

"We are very pleased by the NMPA’s decision to grant Priority Review for SG, reinforcing its potential to serve as a novel and important treatment option to people in China suffering the devastating effects of metastatic triple-negative breast cancer," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "We look forward to working closely with local regulatory bodies to bring this innovative treatment to patients in China as quickly as possible."

"This exciting milestone is one of many recent global clinical and regulatory advances that further enables us to accelerate the pace at which we work to bring this first-of-its-kind therapy to patients in need," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.

In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

Under the trade name Trodelvy, the U.S. Food and Drug Administration (FDA) previously granted accelerated approval to SG in April 2020 and full approval to SG in April 2021 for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

About Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.

About Sacituzumab Govitecan-hziy

Sacituzumab govitecan-hziy (SG) is a first-in-class, antibody and topoisomerase inhibitor conjugate directed at TROP-2, a protein frequently expressed in multiple types of epithelial cancers. SG is approved in the United States under the trade name Trodelvy.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.

The Ministry of Food and Drug Safety (MFDS) in South Korea has granted Fast Track Designation and Orphan Drug Designation (ODD) to SG for the treatment of metastatic TNBC. In addition, Everest announced in January 2021 that it submitted a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for SG for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. That application is currently under review.

On May 20, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported an upcoming poster presentation highlighting its chemotherapy free regimen of interleukin-15 (IL-15) superagonist Anktiva (also called N-803) in combination with checkpoint therapy in patients who had relapsed from checkpoint inhibitors, at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place virtually this year from June 4 through June 8, 2021 (Press release, ImmunityBio, MAY 20, 2021, View Source [SID1234580344]).

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The Phase 2 study, titled "Preliminary data from QUILT 3.055: A Phase 2 multi-cohort study of N-803 (IL-15 superagonist) in combination with Checkpoint Inhibitors (CPI)", details data highlighting the safety and clinical benefit of adding Anktiva to checkpoint inhibitor therapy in second-line or greater treatment regimens in multiple cancer types, a basket trial.

Anktiva is designed to activate natural killer cells and CD8+ T cells, without the activation of T-reg cells that can suppress anti-tumor activity. In this Phase 2 study, Anktiva was administered to each patient in combination with a checkpoint inhibitor that had previously yielded a complete response, partial response, or six months of stable disease in that patient in the setting of first-, second- and third-line therapy before disease progression resumed.

"We are encouraged by the trend to date toward Anktiva’s safety, tolerability and clinical benefit that is robust across several types of historically difficult-to-treat cancers, which aligns with Anktiva’s mechanism of action being agnostic with respect to cancer type," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. "We hope to see durable benefit as the study progresses, which would suggest that Anktiva can confer long-term re-sensitization of tumor tissue to checkpoint inhibitor therapy across several cancer types and patterns of patient history."

Human solid tumors are made of multiple clones of tumor cells, some of which harbor genomic alterations that make them invisible to T cells. These resistant clones accomplish this "cloaking ability" by preventing the presentation of the tumor antigens on MHC-I receptors, thus "hiding" from killer T cells. For these patients, maximum activation of T cells with immunotherapy is unlikely to lead to durable tumor control or a cure. However, when NK cells are activated, tumor recognition and targeting is restored. Anktiva activates both NK and T cells and a potential mechanism of rescuing patients from checkpoint relapse is the administration of Anktiva together with the same checkpoint therapy.

"We hypothesize that checkpoint therapy alone is insufficient and that the combination of Anktiva with or without PD-L1 t-haNK may advance the strategy of developing a chemotherapy free immunotherapy protocol for the treatment of multiple tumors. We have previously demonstrated that PD-L1 t-haNK plays an important role in checkpoint failures. The encouraging data from this Phase 2 exploratory trial has formed the basis of our randomized Phase 3 clinical trials in lung cancer (QUILT 2.023, NCT03520686)" said Dr. Soon-Shiong.

Study highlights to date include:

140 patients with checkpoint relapse accrued across multiple tumor types: NSCLC, Small Cell, Urothelial, Head & Neck, Melanoma, Renal, Gastric, and Cervical cancer
121 evaluable patients to date with preliminary data demonstrating 68% (82 out of 121) disease control (partial response and stable disease >6 weeks)
Anktiva exhibits a favorable toxicity profile in combination with several different checkpoint inhibitors in second-line or greater settings, across a variety of tumor types
Adverse events, 12% of which were grade 3 or above, that were related to the chemotherapy-free combination regimen were favorable to the historical standard of care comprising combination therapies that include chemotherapy
Treatment-related serious adverse events (SAEs) were seen in 8% of study participants
Combination regimens that included Anktiva demonstrated clinical benefit in the majority of subjects, with cessation of progression, prolonged stable disease, and occasional partial responses per RECIST were observed in different tumor types